Purpose: This study aimed to determine the efficacy of the dexamethasone (DEX) intravitreal implant for the regression of macular edema and the improvement of best-corrected visual acuity (BCVA) after the removal of idiopathic epiretinal membrane (ERM). Methods: This prospective randomized controlled trial recruited 81 patients with idiopathic ERM. These patients all underwent 25-gauge pars plana vitrectomy combined with ERM and internal limiting membrane peeling surgery. Among them, 41 eyes in the DEX group received additional DEX implants and 40 in the non-DEX group did not. Outcomes including central retinal thickness (CRT), BCVA, and intraocular pressure were measured 1 and 3 months after surgery. Results: The DEX group had thinner CRTs compared to the non-DEX group at 1 month postoperatively (p <0.05), but did not differ significantly at the 1-week and 3-month follow-up visits (p = 0.109 and p = 0.417, respectively). There were no statistical differences with respect to BCVA (p = 0.499, 0.309, 0.246, and 0.517, respectively) and intraocular pressure (p = 0.556, 0.639, 0.741, and 0.517, respectively) between the two groups at each point of follow-up visits. Conclusion: DEX accelerated the reduction of CRT at 1 month after surgery. However, no evidence of further anatomical (CRT) or functional (BCVA) benefits using DEX was observed at 3 months. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT05416827.

OBJECTIVE: To analyze choroidal parameters in eyes with diabetic macular edema (DME) treated with intravitreal Ozurdex.
METHODS: Twenty eyes of 14 patients were included in this prospective study. Optical coherence tomography images were obtained before and 8-10 weeks after intravitreal Ozurdex injection; binarized and subfoveal choroidal thickness (SFCT) and choroidal vascularity index (CVI) were calculated.
RESULTS: Mean SFCT (treatment naïve; 242.22 ± 32.87 reduced to 218.10 ± 22.10, P = 0.158 and previously treated; 330.4 ± 56.72 reduced to 328.93 ± 50.55, P = 0.833) and mean CVI (treatment naïve; 0.64 ± 0.03 changed to 0.65 ± 0.04, P = 0.583 and previously treated; 0.65 ± 0.05 reduced to 0.64 ± 0.03, P = 0.208) showed no significant change.
CONCLUSIONS: Intravitreal Ozurdex showed no significant effects on SFCT and CVI in eyes with DME over short term. Larger studies with longer follow-up may allow a better understanding.

OBJECTIVE: To assess the effect of the intravitreal dexamethasone implant (DEX) Ozurdex on the best corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients with diabetic macular edema (DME).
METHODS: Totally 43 eyes (24 naïve and 19 previously treated) were included in the study. Retrospective and single-center study involved patients with a clinical diagnosed of DME, who received treatment with DEX implant and had a follow-up of at least 12mo. Primary endpoints included changes in BCVA and CRT.
RESULTS: At month 12, mean improvement in BCVA from baseline was 20.4±20.8 letters and 6.8±6.9 letters in naïve and previously treated patients, respectively (P=0.0132). The naïve patients achieved the BCVA improvement significantly faster (2.4±1.5mo) than the previously treated ones (3.5±2.4mo, P=0.0298; Mann-Whitney test). The proportion of eyes gaining ≥15 letters was 54.2% and 21.1% in the non-previously treated and previously treated groups, respectively (P=0.0293). CRT was significantly reduced from 484.0±119.8 and 487.5±159.9 µm to 272.0±39.2 and 233.5±65.7 µm in the naïve and previously treated patients, respectively; P<0.0001 each, respectively. The presence of subretinal fluid was significantly associated with the proportion of patients achieving a BCVA improvement ≥5 letters [HR (95%CI), 1.23 (1.04 to 1.45), P=0.0145]; ≥10 letters [HR (95%CI), 1.75 (1.10 to 2.77), P=0.0182]; and ≥15 letters [HR (95% CI), 2.04 (1.03 to 4.02), P=0.0407]. Naïve patients received less DEX implants throughout the study than the previously treated ones (1.8±0.6 vs 2.3±0.6, P=0.0172, respectively). Totally 9 patients (20.9%) have developed ocular hypertension, which was successfully controlled with topical hypotensive drugs. Of the 23 phakic eyes at baseline, 5 eyes (21.7%) either had new onset lens opacity or progression of an existing opacity during the study follow-up. Four of them (2 in the naïve group and 2 in the previously treated one) required cataract surgery at months 4, 6, 6, and 6, respectively.
CONCLUSIONS: The results obtained in this study may support the early use of DEX Ozurdex as first line therapy in naïve patients.

UNASSIGNED: There has been an increasing clinical interest in specific retinal parameters as non-invasive biomarkers of retinal inflammation in diabetic macular edema (DME) that have been shown to have prognostic value, such as hyperreflective retinal fields (HRFs) and subfoveal neuroretinal detachment (SND).
UNASSIGNED: We conducted a prospective, non-comparative study of treatment-naïve patients with DME to evaluate the efficacy of a Pro Re Nata (PRN) regimen of intravitreal dexamethasone implant 0.7 mg (DexI, Ozurdex™). After administration, patients underwent subsequent injections according to PRN criteria in case of edema relapse, but not earlier than 4 months after the previous treatment. Patients were evaluated at baseline, within 15 days of injection, and every month thereafter. During all visits, best-corrected visual acuity (BCVA) was recorded; central retinal thickness (CRT), type of edema, presence of SND, and presence and number of HRFs were evaluated using swept-source optical coherence tomography (SS-OCT) 3D. Treatment outcome was defined as changes in BCVA, CRT, SND and HRFs at 12 (T12) and 24 (T24) months compared with baseline (T0).
UNASSIGNED: The study enrolled 24 eyes of 18 patients. The mean duration of follow-up was 18±6.6 months; for all eyes, T12 data were available, while follow-up reached T24 for 12 eyes. BCVA improved significantly and CRT decreased significantly during treatment; the edema was no longer detectable in 13/24 eyes at T12 and 8/12 eyes at T24. No patient presented SND at T12 and T24, and the mean number of HRFs decreased significantly during treatment. Results with CRT and HRFs correlated with BCVA at 12 and 24 months. No significant adverse events were observed.
UNASSIGNED: In patients with DME, the intravitreal dexamethasone implant was effective and safe in improving both functional and tomographic parameters. This result is consistent with improvement in biomarkers of inflammation.

UNASSIGNED: To describe a case of retinal lymphoma presenting as an occlusive retinal vasculitis without vitritis that was exquisitely responsive to intravitreal dexamethasone implant (IVDI).
UNASSIGNED: A 66-year old male presented with decreased vision in the right eye and was diagnosed with occlusive retinal vasculitis and prominent cystoid macular edema though he lacked vitritis. A complete systemic workup for infectious, inflammatory, and infiltrative etiologies was unremarkable. Intravenous methylprednisolone and cyclophosphamide had no clinical effect. Due to persistent perivascular exudates and refractory macular edema, IVDI was administered with marked improvement in vision and clinical findings. Subsequent retinal vasculitis in the left eye responded to IVDI as well. The patient remained disease free for months while on weekly adalimumab. He then presented with acute vision loss in the left eye due to a lymphomatous subretinal infiltration and a new lesion in the corpus callosum. He has remained disease free for more than two years after intravitreal methotrexate injections and rituximab with an autologous stem cell transplant.
UNASSIGNED: Lymphoma may present as an occlusive retinal vasculitis without vitritis and can be masked due to its response to IVDI.

OBJECTIVE: The purpose of this study is to evaluate the predictive capacity of the baseline hyperreflective dots (HRDs) on the functional and anatomical response in patients with diabetic macular edema (DME). Additionally, we assessed the impact of the intravitreal dexamethasone (DEX) implant on the functional and anatomic outcomes.
METHODS: Retrospective, multicenter study. The number of HRDs was graded in four different stages: [A] none HRDs; [B] few, 1-10 HRDs; [C] moderate, 11-20 HRDs; and [D] many, ≥ 21 HRDs. For statistical purposes, groups A and B were combined [scarce HRDs (S-HRDs)] and group D was renamed as [abundant HRDs (A-HRDs)]. The primary endpoints were the mean change in best corrected visual acuity (BCVA) and central macular thickness (CMT) according to baseline HRD stage.
RESULTS: One hundred eyes from one hundred patients were included in the study. Mean BCVA significantly improved from 52.9 (50.0 to 55.8) letters ETDRS at baseline to 57.2 (54.0 to 60.4) letters at month 6, p = 0.0039. There were no significant differences between the S-HRDs and A-HRD study groups in BCVA. As compared to baseline, CMT reduction was 106.3 (59.8 to 152.7) μm and 94.2 (34.7 to 153.7) μm in S-HRDs and A-HRD groups, respectively (p < 0.0001 each, respectively). Twenty-three (65.7%) and 18 (62.1%) eyes achieved a CMT reduction ≥ 10% in the S-HRD and A-HRD groups, respectively, p = 0.7640. DEX implant significantly reduced the presence of outer nuclear layer (ONL) disruptions (p = 0.0010).
CONCLUSIONS: The number of HRDs did not influence either functional or anatomic outcomes. DEX implant significantly decreases the number of eyes with ONL disruptions, which might improve retinal integrity.

Objective: To evaluate the mid-long-term efficacy and safety of the dexamethasone intravitreal (DEX) implant (Ozurdex1) in naïve patients with diabetic macular edema (DME).Methods: Prospective and single-center study conducted on consecutive patients with a diagnosis of DME, who received a DEX implant and were followed up for at least 12 months. The main outcomes measurements were the mean change in best corrected visual acuity (BCVA) and in foveal thickness (FT) as compared to the baseline values.Results: Of the 84 screened patients 50 were included in the study. The BCVA significantly improved from 52.4 (20.4) letters at baseline to 62.6 (15.6), 61.2 (18.4), 61.6 (18.6), 60.6 (19.0), and 60.6 (18.8) at 2, 4, 6, 12 months and end of follow-up period, respectively (repeated measures ANOVA and the Greenhouse-Geisser correction; p = .0008). At the end of the follow-up period, a gain of BCVA of ≥5, ≥10, and ≥15 letters were observed in 26 (52.0%), 18 (36.0%), and 16 (32.0%) patients, respectively. The mean FT was significantly reduced from 446.0 (139.9) µm at baseline to 327.2 (103.6) at the end of follow-up (repeated measures ANOVA and the Greenhouse-Geisser correction; p = .0008). During the study follow-up, the patients receive a mean of 3.4 (2.9-3.9) implants. Of the 32 phakic eyes at baseline, 17 (53.1%) either developed new lens opacity or progression of an existing opacity.Conclusion: In eyes with DME not previously treated with intravitreal drugs, DEX implants provide meaningful functional and anatomical benefits, and these results are sustained mid-long-term.

OBJECTIVE: This study aimed to evaluate the effect of dexamethasone implantation on the hard exudates (HEX) in patients with diabetic macular edema (DME).
METHODS: This was a nonrandomized open-label single-center prospective trial.
METHODS: This study included 15 eyes of 11 subjects with DME. Key inclusion criteria were naïve eyes with DME with HEX within 3 mm of fovea with center-involving DME; central macular thickness (CMT) >250 μm at baseline; best-corrected visual acuity (BCVA) between 20/400 and 20/40. Key exclusion criteria were previous intraocular surgery and history of panretinal photocoagulation (PRP) in past 4 months. The primary outcome measure was change in total HEX area at the macula (in mm2) measured by semiautomated algorithm. Secondary outcome measures were change in visual acuity, low-contrast visual acuity (LCVA), retinal sensitivity (RS) on macular microperimetry, and CMT.
RESULTS: The total HEX area reduced from 1.5 mm2 (±1.46 mm2) at baseline to 0.89 mm2 (±1.062 mm2) at the final visit (p=0.185). The CMT improved significantly (p=0.03) from 488.67 μm (±240.66 μm) to 326.93 μm (±135.84 μm) at the final visit. Mean BCVA remained stable (p=0.95) (50.93±16.65 at baseline and 50.6±18.95 at final visit). The mean LCVA and RS showed insignificant improvement (p=0.31 and p=0.28, respectively).
CONCLUSIONS: Our pilot study demonstrated an improving trend in reduction of total HEX area and other anatomical outcomes, with limited functional outcomes. Larger randomized studies with a larger sample size with a control group are warranted to establish management protocols for DME with significant subfoveal HEX.

BACKGROUND: The objective of this study is to evaluate the influence of repeated intraocular dexamethasone implant (Ozurdex) injections on metabolic control in type 2 diabetic patients.
METHODS: Retrospective study of 165 type 2 diabetic patients starting Ozurdex treatment who received no less than three consecutive injections. Glycated hemoglobin (HbA1c), serum creatinine, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides (TGs) were evaluated during 15 months of follow-up after Ozurdex treatment onset.
RESULTS: Fifty-seven patients met inclusion criteria. Mean baseline values for HbA1c, creatinine, total cholesterol, HDL cholesterol, and TGs before treatment (7.1%, 1.3, 176.7, 51.1, and 125.6 mg/dl, respectively) were similar to mean values after Ozurdex onset (Wilcoxon test p values were 0.68, 0.41, 0.06, 0.87, and 0.33, respectively) and remained stable during the follow-up period. Mean LDL cholesterol levels increased slightly after Ozurdex treatment onset (90.1 vs 88.2 mg/dl, p = 0.04) but after 15 months of follow-up they had returned to baseline values. Transient increase in LDL cholesterol was remarkable in the group of 24 bilaterally treated patients (96.8 vs 88.4 mg/dl, p = 0.03). A third of these patients increased their baseline LDL values by more than 20%. Even with continuous injections of Ozurdex, LDL cholesterol levels also declined back to baseline by month 15.
CONCLUSIONS: Ozurdex injections had no influence on HbA1c or renal function. Lipid profile changes were mild and transient. However, a significant temporary increase has been found in LDL cholesterol levels in patients receiving simultaneous bilateral injections. Lipid levels should be monitored in patients starting with bilateral Ozurdex injections especially in those with recent history of acute myocardial infarction.

OBJECTIVE: To evaluate a pro re nata administration of Ozurdex® implant versus a single administration for treating diabetic macular oedema (DME).
METHODS: This exploratory study is designed as a comparative, multicentre, randomized study with a follow-up of 6 months. Patients with DME were assigned to treatment at baseline either with a single Ozurdex® implant during the entire six-month follow-up (fixed group) or Ozurdex® implant followed by retreatment on an individualized basis (PRN group). Patients were scheduled for monthly evaluation based on assessment of best-corrected visual acuity (BCVA) and optical coherence tomography.
RESULTS: Twenty eyes were enrolled to the PRN group, and 22 were included in the fixed group. Following an equally steady, initial gain up to month 1, and maintenance up to month 3, vision started to decline in the fixed regimen group. At 6 months, a difference of 0.11 logMAR in BCVA was observed in favour of the PRN group. Compared to baseline, a significant reduction in retinal thickness was achieved up to month 2, when the fixed regimen group had begun to revert to pretreatment level. At 4 and 5 months, the difference in thickness between the two groups was statistically significant (p < 0.05). Mean number of treatments was 1.6 in the PRN group. Both fixed and PRN administration of Ozurdex showed a good safety profile.
CONCLUSIONS: A personalized treatment with monthly monitoring and retreatment as needed is effective in maintaining functional and anatomical benefits of Ozurdex® .